Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD
Brief summary
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.
Interventions
DRUGABT-089
Open label study, subjects will take up to 80mg daily for 24 months.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period * If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study * If female, the result of a pregnancy tests are negative * The subject is judged to be in generally good health
Exclusion criteria
* More than 7 days have elapsed since the last dose of study drug in Study M06-855 * The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study * The subject anticipates a move outside the geographic area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAARS:INV | Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
| CGI-ADHD-S | Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
Secondary
| Measure | Time frame |
|---|---|
| AAQoL | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 |
| WPAI | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 |
| RUQ | Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 |
| FTND | Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
Countries
United States
Outcome results
None listed